KYPROLIS Drug Patent Profile

When do Kyprolis patents expire, and when can generic versions of Kyprolis launch?

Kyprolis is a drug marketed by Onyx Pharms Amgen and is included in one NDA. There are four patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and twenty patent family members in forty-two countries.

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kyprolis

A generic version of KYPROLIS was approved as carfilzomib by DR REDDYS on September 9^th, 2019.

Summary for KYPROLIS

International Patents:	220
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	95
Patent Applications:	4,016
Drug Prices:	Drug price information for KYPROLIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KYPROLIS
What excipients (inactive ingredients) are in KYPROLIS?	KYPROLIS excipients list
DailyMed Link:	KYPROLIS at DailyMed

See drug prices for KYPROLIS

Recent Clinical Trials for KYPROLIS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wuhan Union Hospital, China	Phase 2
Dong-A University Hospital	Phase 2
GlaxoSmithKline	Phase 2

See all KYPROLIS clinical trials

Pharmacology for KYPROLIS

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Paragraph IV (Patent) Challenges for KYPROLIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KYPROLIS	For Injection	carfilzomib	10 mg/vial	202714	1	2018-11-28
KYPROLIS	For Injection	carfilzomib	30 mg/vial	202714	1	2017-10-05
KYPROLIS	For Injection	carfilzomib	60 mg/vial	202714	9	2016-07-20

US Patents and Regulatory Information for KYPROLIS

KYPROLIS is protected by four US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	Yes					Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes					Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	Yes					Y

Expired US Patents for KYPROLIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016

EU/EMA Drug Approvals for KYPROLIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amgen Europe B.V.	Kyprolis	carfilzomib	EMEA/H/C/003790Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.	Authorised	no	no	yes	2015-11-19

International Patents for KYPROLIS

When does loss-of-exclusivity occur for KYPROLIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KYPROLIS around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2014221805	ペプチドエポキシケトンを用いた併用療法 (COMBINATION THERAPY WITH PEPTIDE EPOXYKETONE)
Russian Federation	2747757	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (COMPOSITIONS OF ALKYLATED CYCLODEXTRIN AND METHODS OF THEIR PREPARATION AND APPLICATION)
Mexico	390762	COMPOSICIONES DE CICLODEXTRINA ALQUILADA Y PROCESOS PARA PREPARAR Y UTILIZAR LAS MISMAS (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME)
Mexico	368109	TERAPIA DE COMBINACION CON EPOXICETONAS PEPTIDICAS. (COMBINATION THERAPY WITH PEPTIDE EPOXYKETONES.)

Supplementary Protection Certificates for KYPROLIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781688	625	Finland
1781688	PA2016010,C1781688	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	PA2016010	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	C 2016 014	Romania		PRODUCT NAME: CARFILZOMIB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1060; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1060; DATE OF FIRST AUTHORISATION IN EEA: 20151119

Market Dynamics and Financial Trajectory of KYPROLIS (Carfilzomib)

Last updated: February 19, 2026

What is the current market position of KYPROLIS?

KYPROLIS (carfilzomib) is a proteasome inhibitor approved by the FDA in July 2015 for relapsed multiple myeloma in adult patients. It is marketed by Amgen. As of 2023, it has maintained a leading position in its niche but faces competition from other agents like bortezomib (Velcade) and newer proteasome inhibitors.

Sales and Revenue Data

• 2022 global sales: Approx. $1.2 billion (Verify from company annual reports)
• Market share in multiple myeloma treatment: Estimated at 25-30% within US and European markets, trailing behind Velcade but ahead of newer agents such as marizomib.

Sales are driven by approvals for various indications, including combination regimens and newly diagnosed settings in combination with other agents like dexamethasone or daratumumab.

How does market demand influence KYPROLIS’s financial trajectory?

Key Drivers

• Efficacy in relapsed/refractory multiple myeloma (RRMM): Proven to improve progression-free survival (PFS), especially in patients resistant to other therapies.
• Increased treatment lines: Growing adoption in second-line and combination regimens supports revenue stability.
• Pricing strategies: Given its orphan drug status, KYPROLIS benefits from premium pricing, although reimbursement pressures exist.

Market Challenges

• Competitive landscape: Bortezomib holds a dominant position; newer agents (e.g., selinexor, melflufen) threaten growth.
• Orphan drug exclusivity: Expired in some regions, allowing biosimilar competition.
• Treatment paradigm shifts: Emergence of immunotherapies, such as CAR-T cell therapies, may impact multiple myeloma treatment landscape and KYPROLIS’s demand.

What financial trends are projected for KYPROLIS?

Revenue Forecast

• 2023-2025 growth rate estimates: 3-5%, factoring in increased penetration and label expansions.
• Potential for plateauing: Trend indicates possible revenue stabilization due to market saturation and competition.
• Impact of new combinations: Enrollment in clinical trials exploring KYPROLIS with monoclonal antibodies may extend revenue lifecycle.

Cost and Profitability Metrics

• Gross margins: Historically above 85%, driven mostly by manufacturing efficiencies.
• Research and Development (R&D): Ongoing clinical trials increase expenses; however, amortized R&D costs covered within corporate budgets.
• Pricing pressures: Reimbursement challenges may affect profit margins, especially in regions with cost-containment policies.

How might regulatory and policy developments influence KYPROLIS’s market?

• Regulatory approvals: Extensions or expansions via supplemental indications could bolster sales.
• Patent landscape: Patent expiry dates, including potential generic entry post-exclusivity, may reduce revenue.
• Health technology assessments: Payers may impose stricter formulary controls affecting reimbursement levels.

Summary of competitive and market risks

Factor	Market Impact
Increased biosimilar activity	Price erosion
Emergence of CAR-T therapies	Decreased demand for proteasome inhibitors for certain patient groups
Label expansion approvals	Revenue increase
Patent expiry	Potential revenue decline

Key Takeaways

• KYPROLIS remains a significant player in relapsed multiple myeloma therapy with approximately $1.2 billion in global sales in 2022.
• Market growth is constrained by competition from established agents like Velcade, as well as emerging therapies.
• Revenues are projected to grow modestly through 2025, driven by label expansions and combination use.
• Pricing pressures and patent expirations pose risks to future profitability.
• Regulatory strategies, clinical trial outcomes, and competition from immunotherapies will determine long-term market position.

FAQs

Q1: Will KYPROLIS face biosimilar competition soon?
A1: Likely after patent expiry, biosimilar options could enter the market, impacting pricing and sales.

Q2: How does KYPROLIS compare financially to other myeloma therapies?
A2: It generates solid revenue but trails behind Velcade, with newer agents starting to gain acceptance.

Q3: What populations are driving growth for KYPROLIS?
A3: Patients with relapsed/refractory multiple myeloma, especially those resistant to earlier therapies.

Q4: Are there ongoing clinical trials that could expand KYPROLIS's use?
A4: Yes, trials combining KYPROLIS with monoclonal antibodies and investigating earlier treatment lines are ongoing.

Q5: What is the primary regulatory challenge for KYPROLIS?
A5: Patent protections are finite; loss of exclusivity could permit generic competitors.

References

[1] Amgen. (2022). KYPROLIS (Carfilzomib) Prescribing Information.
[2] EvaluatePharma. (2023). World Market Data for Multiple Myeloma Drugs.
[3] U.S. Food and Drug Administration. (2015). KYPROLIS approvals.
[4] IMS Health. (2022). Pharmaceutical Market Data.
[5] ClinicalTrials.gov. (2023). KYPROLIS Clinical Trials Database.